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Radar On Market Access: Step Therapy for Part B Drugs

Posted by Matt Breese on Aug 14, 2018

In a move that industry analysts see as a positive development for the managed care sector, CMS issued new guidance that will allow Medicare Advantage (MA) plans to use step therapy for Part B drugs starting in 2019, AIS Health reported.
 
CMS is giving MA plans that offer a Part D benefit the ability to "cross-manage" drugs across Part B and Part D. In other words, plans could require patients to try alternatives covered within Part D before moving on to relatively expensive physician-administered drugs in Part B, Credit Suisse analyst A.J. Rice explained in a research note.
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Topics: Specialty, Industry Trends, Market Access

Perspectives on REMS Programs

Posted by Matt Breese on Aug 9, 2018

The FDA’s Risk Evaluation and Mitigation Strategy initiative — under which the agency requires pharmacy manufacturers to develop a REMS program for certain therapies in order to manage risks while still allowing people to have access to it — may present challenges to many stakeholders. But manufacturers in particular may use REMS to their advantage, AIS Health reported.
 
According to Glenn Carroll, principal at Deloitte, one of the top challenges that manufacturers may grapple with is the "increasing complexity of developing and administering" REMS. He says, "many of the REMS being developed today are more rigorous to implement than what we’ve seen in the past."
 
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Topics: Specialty, Industry Trends, Provider, Payer

Radar On Market Access: New Class of Migraine Drug Drives Changes

Posted by Matt Breese on Aug 9, 2018

For years, clinicians have mostly prescribed generic prescription drugs to treat migraines. But a new class of relatively high-cost specialty biologic products is threatening to upend payers' calm, AIS Health reported.
 
Current migraines treatments supported by clinical evidence "include beta blockers, tri-cyclic anti-depressants and some seizure medications," according to Mesfin Tegenu, R.Ph., president of PerformRx, LLC. The situation changed in mid-May, when Amgen, Inc and Novartis AG's Aimovig got the regulatory greenlight in the U.S., and two more calcitonin gene-related peptide (CGRP) inhibitors — Teva Pharmaceuticals' fremanezumab and Eli Lilly and Co.'s galcanezumab — are under FDA review, says an Institute for Clinical and Economic Review (ICER) report on migraine treatments.
 
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Topics: Specialty, Industry Trends, Market Access, Payer

Radar On Market Access: Drug-Diagnostic Co-Development

Posted by Matt Breese on Aug 7, 2018

As knowledge around biomarkers grows, more drugs are coming onto the market with FDA-approved labels indicating their use with a particular diagnostic test. With most manufacturers nowadays choosing not to develop their own companion diagnostic but rather to partner with an outside firm, pharma companies need to be able to incorporate a diagnostic strategy into their drug development approach, AIS Health reported.
 
Previously some companies would develop both the drug and the diagnostic, but the number that now do so has declined. According to Amit Agarwal at Deloitte Consulting LLP, "diagnostic is a very different margin and business model than the pharmaceutical industry….The economics of it differ pretty dramatically."
 
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Topics: Specialty, Industry Trends, Product Release, Provider

Trends That Matter for Generic Drugs

Posted by Matt Breese on Aug 2, 2018

The Trump administration has touted competition as one way to bring down drug prices. With this goal in mind, the FDA recently released a pair of draft guidance documents aimed at helping generics get onto the market sooner while still upholding the focus on safety, AIS Health reported. 

One of the documents, titled Development of a Shared System Risk Evaluation and Mitigation Strategy (REMS) (83 Fed. Reg. 25468, June 1, 2018), offers recommendations for developing a shared system REMS for multiple drug products. 

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Topics: Specialty, Industry Trends, Payer

Radar On Market Access: Generic Firm as "Societal Asset"

Posted by Matt Breese on Aug 2, 2018

Earlier this year, Intermountain Healthcare teamed up with other health systems to start building a not-for-profit generic drug manufacturing business, with a goal to create "what we think…[is] a first-of-its-kind societal asset," said Dan Liljenquist, vice president of Intermountain Healthcare's Enterprise Initiative Office.
 
"Essentially, we're going to set this up where the governing members of this organization are going to act more like public service commissioners and build a public-utility-type model for the manufacturing and distribution of essential generic medications," he said.
 
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Topics: Specialty, Industry Trends, Data & Analytics, Payer

Perspectives on Amazon/PillPack Deal

Posted by Matt Breese on Jul 26, 2018

Amazon recently unveiled its plan to purchase PillPack — a tech-enabled startup that offers pre-sorted dose packaging and home delivery of prescription drugs for those taking multiple medications — yet industry analysts do not appear convinced that the acquisition will have a significant effect on PBMs or health insurers, at least not in the short term, AIS Health reported.
 
Credit Suisse's A.J. Rice wrote in a research note, "We do not expect any material impact on our financial expectations for the MCOs we cover and thus we make no change to our estimates or ratings." 
 
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Topics: Industry Trends, Market Access, Provider, Payer, Branding & Marketing

Radar On Market Access: Initiative Focuses on T790M Mutation

Posted by Matt Breese on Jul 26, 2018

While tumor testing occurs following an oncology diagnosis, that may not be the only time testing for a mutation is needed. For example, within epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC), many patients will develop another mutation, T790M, that can lead to treatment resistance and disease progression. Avella Specialty Pharmacy has an initiative, known as "Know Your Next Steps," designed to educate people about the importance of the test and the fact that there is a therapy available to treat this certain subsection of patients, AIS Health reported.
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Topics: Specialty, Industry Trends, Payer

Radar On Market Access: Varied Multiple Myeloma Therapies Exist

Posted by Matt Breese on Jul 24, 2018

Although multiple myeloma is a relatively rare cancer, numerous therapies to treat it are available, AIS Health reported. Because of these products' efficacy, they have made the disease manageable — and, as a result, costly.
 
"The mainstays of treatment for multiple myeloma are considered specialty medications and therefore placed into a specialty tier," says Raechele McMahan, vice president and general manager, enterprise specialty pharmacy at Prime Therapeutics. "The therapies are also subject to utilization management, which primarily consists of prior approval."
 
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Topics: Specialty, Industry Trends, Market Access, Payer

Radar On Market Access: Clover Health Offers Pharmacogenomics Testing

Posted by Matt Breese on Jul 17, 2018

In-home primary care has become a de rigueur offering for Medicare Advantage (MA) organizations looking to avoid costly emergency room visits and hospital admissions. Clover Health aims to innovate the traditional multidisciplinary structure with pharmacogenomic testing that could lead to safer and more effective medication use, AIS Health reported. 
 
Clover currently serves about 600 frail, chronically ill members in its home care program, who on average have between six and 11 chronic conditions and are on 10 or more medications. The insurer in June began offering genetic testing capabilities provided by YouScript, a proprietary clinical decision support tool designed to assist in medication therapy management.
 
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Topics: Industry Trends, Data & Analytics, Payer